FDA Proposes New Health Claim Procedures

WASHINGTON--The Food and Drug Administration (FDA) came up with a game plan for health claims appearing on dietary supplements and food. On July 10, FDA's Task Force on Consumer Health Information for Better Nutrition (www.fda.gov/oc/mcclellan/chbn.html) unveiled a new process to provide more science-based, FDA-regulated information about the health consequences of foods and dietary supplements on product labels. The task force, made up of government experts on health information and nutrition from FDA, the Federal Trade Commission (FTC) and the National Institutes of Health (NIH), proposed a two-phase plan--which includes the steps companies should take for getting a health claim approved--to improve consumer understanding of the health consequences of their dietary choices. FDA intends to use the interim procedures to ensure that its pre-market review is consistent with the spirit of the Nutrition Labeling and Education Act (NLEA) and the First Amendment.

"Protecting consumers by helping them get better nutrition information is among FDA's top priorities, because the choices that Americans make about their diet have a great impact on the health of the public," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "This new initiative will better protect consumers from making uninformed or misinformed choices about their diet and nutrition, by giving consumers better information about the health consequences of those choices." He added the review process for making qualified claims, combined with FDA enforcement, will reward companies that make healthier products while more aggressively enforcing the law against companies that appeal to consumers through false and misleading health claims.

In support of the task force's efforts, FDA made available two final guidance documents in the June 10 Federal Register. The first, "Guidance: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements," explains how applicants can seek a qualified health claim for food or dietary supplements during the first phase of this initiative. It also describes how FDA will set priorities for reviewing qualified health claims petitions most likely to have important public health benefits.

The second document, "Guidance: Interim Evidence-based Ranking System for Scientific Data," describes a process for systematically evaluating and ranking the scientific evidence for a qualified health claim. This ranking system will categorize the quality and strength of the scientific evidence. For example, grades of "B," "C" or "D" will be given to every proposed, qualified health claim.

The highest grade, "A," indicates significant scientific agreement about the health claim. Evidence supporting said claim will be based on well-designed studies conducted in a manner consistent with generally recognized scientific procedures and principles. Such a claim requires no disclaimer and is therefore referred to as an "unqualified health claim." A current example of an "A" health claim, according to FDA, would be calcium's benefits for osteoporosis.

Health claims graded "B," "C" or "D" are referred to as "qualified health claims"; they require a disclaimer or other qualifying language to ensure they do not mislead consumers. A "B" grade would be assigned to those petitions for which there is good scientific evidence supporting the claim, but for which the evidence is not entirely conclusive. FDA reported claims such as omega-3s' link to cardiovascular health would fall under this heading. A "C" grade would apply to claims for which the evidence is limited and inconclusive, while a "D" grade would be given to claims with little scientific evidence to support them. More on the ranking system can be found on FDA's site (www.fda.gov/OHRMS/DOCKETS/98fr/03N-0069-gdl0001.pdf).

The agency intends to begin applying these interim guidances for health claim petitions submitted on or after Sept. 1, 2003. Within 45 days of receipt of a qualified health claim petition, FDA intends to determine whether the petition is complete; once it is, the agency intends to file the petition. FDA recognizes that it can evaluate petitions more efficiently and effectively if they are well-organized and contain all the relevant information. FDA encourages potential petitioners to meet with the agency prior to preparing a petition to discuss their plans.

FDA plans to prioritize claims on a case-by-case basis, factoring in whether the food or dietary supplement that is the subject of the petition is likely to have a significant impact on a serious or life-threatening illness; the strength of the evidence; whether consumer research has been provided to show the claim is not misleading; whether the substance of the claim has undergone an FDA safety review (i.e., is an authorized food additive, has been self-affirmed GRAS [generally recognized as safe]); whether the substance that is the subject of the claim has been adequately characterized so that the relevance of available studies can be evaluated; whether the disease is defined and evaluated in accordance with generally accepted criteria established by a recognized body of qualified experts; and whether there is prior review of the evidence or the claim by a recognized body of qualified experts.

Upon filing a petition, FDA intends to post the petition on its Web site and request public comment for 60 days.

After the comment period closes, FDA may pursue any one of several options for scientific review of data submitted in a petition in support of the substance/disease relationship. FDA may conduct the review internally, it may convene an advisory subcommittee, or it may use appropriate third-party reviewers under contract to FDA, such as the Agency for Healthcare Quality and Research (AHRQ).

On or before day 270 after receipt of the filed petition, FDA plans to notify the petitioner in a letter of: a) the agency's determination; b) the basis for its determination; and c) if the agency decides to consider exercising enforcement discretion, the qualified claim for which the agency intends to consider exercising such discretion and the provisions of 21 CFR 101.14 for which the agency intends to consider exercising such discretion. FDA also plans to notify the petitioner of any other factors the agency intends to consider in deciding whether to exercise enforcement discretion when the claim appears in labeling of conventional human food or dietary supplements.

FDA is conducting further consumer research to make sure that the language used is easily and accurately interpreted by consumers. FDA will also complete, and encourage other research groups to complete, a consumer studies research agenda designed to improve understanding of the most effective way to present scientifically based, truthful and non-misleading information to consumers--as well as identify the kinds of information known to be misleading.

According to Joseph Levitt, director at FDA's Center for Food Safety and Applied Nutrition (CFSAN), "If companies do their own consumer research data, that would be one criteria that would help move them further along to the front of the line."

In support of this new measure, FDA has refocused its Applied Nutrition programs in its Center for Food Safety and Applied Nutrition, to provide additional resources for, and senior staff involvement in, the "Consumer Health Information for Better Nutrition" initiative. For example, FDA has established new policy expert positions in the Office of the Commissioner on nutrition, risk management and risk communication to assist in these applied nutrition activities. FDA is also establishing closer ties between its dietary supplement program and the experts in its drug program who have extensive professional knowledge of the medical risk factors for various diseases. Plus, FDA is enhancing its enforcement activities related to misleading claims about the health benefits of products, particularly dietary supplements, that are not supported by scientific evidence.

These moves are part of FDA's effort to implement the Pearson v. Shalala court decision that found FDA could not reject health claims unless the claims were both misleading and that no disclaimer would clear the misunderstanding. In 2002, the FDA was challenged by the judicial system for violating the protection afforded to company claims proffered under the First Amendment. As a result, FDA issued a request for public comment in the May 16, 2002, Federal Register as to what its boundaries should be for limiting commercial speech.

"This process is one that will allow us to get a handle on the recent series of court losses related to the times FDA has said a claim cannot be allowed rather than letting it go forward with the appropriate qualification," McClellan said during the June 10 conference. "There may be things we learn from this process that we can relate to structure/function claims. We'll see."

McClellan admitted it may be a long shot for a claim to get an "A" rating. "It's hard to get above a B claim and we haven't seen many claims come in at that level in the last decade because the evidence standard is high and it's hard to do that level of research on food nutrition," McClellan told INSIDER. "However, that's why we think it's important to give people access to the information that's been developed by nutritional science over the past decade. If health claims are already out there, they're fine." Those health claims already established, such as soy for heart health and fiber for cholesterol levels, are already considered "A" claims, he added.

Industry Comment

Not since FDA's Good Manufacturing Practices (GMPs) came out in March has there been such a stir in the industry. For one, the Grocery Manufacturers of America (GMA)--reportedly the ones to propose this pre-market notification system in May 2003--was pleased with FDA's actions. "The ability to use qualified health claims by the food industry will provide food manufacturers with new incentives to develop and market new, healthier-for-you products," said Alison Kreser, R.D., director of scientific and nutrition policy.

David Seckman, executive director of the National Nutritional Foods Association (NNFA), found FDA to be moving in the right direction. "These proceducres will allow the manufacturer to provide more accurate and relevant information to consumers. That's a definite plus, both for the consumers and the manufacturers. FDA's health claim procedure clearly supports an industry like ours."

It still remains to be seen how the new health claim procedure will affect the well-being of the industyr. At the 12th Annual Conference of the Functional Foods for Health Program, held at the University of Chicago, Ill., Peter Barton Hutt of the law firm Covington & Burling (www.cov.com), spoke at length on FDA's proposed health claim process. In particular, he made mention of FDA's wording for its grading system: "The Constitution does not say that FDA can create its own dictionary."

Jonathan Emord of Emord Associates P.C. (www.emord.com), an industry-recognized expert in health claim petitions, saw this announcement as a "good thing." "The commissioner has made a bold move in the right direction to ensure American consumers get more and more accurate information about nutrients on disease," he said. "The FDA can characterize the relevant level of [a claim's] strength as scientists see it as long as those characterizations are reasonable. The critical factor is that people get more of this cutting-edge information about the effects of different nutrients on disease. Some of it's well-established, some of it's preliminary--but all of it should be available to the public to assess."